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Technician Bulk Manufacturing.

vor 2 Monaten

Les Brenets NE, Schweiz WuXi AppTec Vollzeit

Le Technician Bulk Manufacturing aura pour mission d’assurer les activités de fabrication des produits (capsules ou comprimés), dans le respect de la réglementation BPF / cGMPs, des règles d’hygiène, et de sécurité. Il devra se conformer aux procédures définies par le système qualité du site pharmaceutique.

  • Réaliser des opérations de production tel que la pesée des matières, la préparation des mélanges de poudre ainsi que la conduite de ligne automatisée dans les activités de capsules ou de comprimés suivant son curriculum de formation et selon les procédures en vigueur du système qualité.
  • Supporter techniquement les opérateurs dans les activités de production.
  • Maitriser l’outil ERP (MES) dans la gestion des dossiers de lot et des consommations associées.
  • Maîtriser et effectuer le nettoyage des équipements du matériel et des salles liées aux différentes étapes de production.
  • Effectuer les changements de format et le vide de ligne production.
  • Mettre à jour et créer des documents techniques nécessaires au fonctionnement des équipements et de la ligne (instructions d’utilisation, de nettoyage).
  • Se conformer aux directives et instructions définies dans le système qualité de notre site pharmaceutique.
  • Assurer la réalisation des opérations de production des lots industriels en environnement GMP et travailler de façon autonome et efficace selon les consignes de son responsable.
  • Contrôler, enregistrer et compléter les documents de travail préétablis pour assurer un suivi des opérations réalisées (dossiers de lots remplis selon les BPF / GMP).
  • Effectuer les contrôles physiques élémentaire des produits fabriqués.
  • Participer et être support à la validation des procédés industriels et à la fabrication des lots de validation.
  • Se conformer aux objectifs de production notamment au respect du planning établi.
  • Générer les demandes d’intervention de maintenance en cas de panne d’équipements et assurer le suivi jusqu’à la reprise de la production.
  • Analyser les pannes d’équipements et être support à la maintenance en cas d’intervention.
  • Ouvrir des déviations dans le système informatique qualité.
  • Réaliser les changements de formats et réglages de base définis dans les procédures.
  • Etre référent technique pour les opérateurs.
  • Former les nouveaux collaborateurs et les opérateurs sur les différentes lignes de production et être le réfèrent de la formation (On the Job Qualified Trainer).
  • Se conformer aux règles de sécurité et de sureté du site pharmaceutique.
  • Annoncer les situations dangereuses, les presqu’accidents/incidents et les accidents qui pourraient survenir sur le site auprès de son responsable direct et auprès du département EHS.

Experience / Education

  •   Avoir une formation initiale de niveau CFC et une expérience de 5 ans dans la production pharmaceutique ou idéalement 3 ans comme technicien dans l’industrie Pharmaceutique.

  Knowledge / Skills / Abilities:  

  • Connaître parfaitement l’environnement BPF / GMP, et avoir une bonne connaissance de l’industrie pharmaceutique, notamment dans le secteur des mélanges et de l’encapsulation et/ou compression de poudres
  • Avoir une parfaite maîtrise du français et des notions d’anglais (A2).
  • Etre organisé et rigoureux, et avoir de grandes qualités relationnelles pour un travail d’équipe.
  • Communiquer de façon claire avec les services support
  • Avoir un esprit critique et est force de proposition dans un but d’amélioration continue.
  • Avoir des connaissances des outils informatiques (Word, Excel) et d’un MES.
  • Partager son savoir et former les nouveaux collaborateurs, opérateurs sur les différents équipements de la zone bulk.

 

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

 

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.